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ARC Skin Protectant ALLANTOIN .5 g/100g Ointment, 100 g — NDC 69148-0001-02 package photo

ARC Skin Protectant ALLANTOIN .5 g/100g Ointment, 100 g

by Anjon Biologics, Inc · 100 g in 1 TUBE (69148-001-02)
NDC 69148-0001-02
🏷️ FDA NDC (as labeled) 69148-001-02 billing pads the product segment with a zero
This package
Contains100 g Pack sizes3 compare ↓
Also comes in: 60 g 69148-0001-01 118.6 g 69148-0001-00
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 69148-001-02
Product NDC 69148-001
11-digit billing NDC 69148000102
RxCUI 1044541
UNII 344S277G0Z
Application # M016
SPL Set ID f4ff79dd-cb38-4cca-9631-a2758a171873
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-08-06
Route TOPICAL
Dosage form OINTMENT
Substance ALLANTOIN
Why two NDCs? The FDA registers this code as 69148-001-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 69148-0001-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerAnjon Biologics, Inc
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code69148
First marketedAug 2014
Product typeHuman Otc Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

ARC Skin Protectant is an over-the-counter topical ointment containing allantoin, an active ingredient commonly used in skin care products to help protect and soothe the skin. Allantoin is typically included in products meant for minor skin irritation and wound care. This product is marketed under the FDA's over-the-counter monograph rules for skin protectants rather than as an individually reviewed drug application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII BYR0546TOW
    DMDM hydantoin is a preservative chemical used to prevent the growth of bacteria and fungi in medicines. It helps keep the product safe and stable throughout its shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII CR6K9C2NHK
    A synthetic preservative derived from methylparaben. It prevents bacterial and fungal growth in medicines, extending shelf life and maintaining product safety during storage.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII QX10HYY4QV
    Sesame oil is a plant-derived oil from sesame seeds. It's used in medicines as a solvent or carrier to dissolve or suspend active ingredients, helping them mix evenly throughout the formulation.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 6LUM696811
    A waxy substance derived from sorbitol and stearic acid. It acts as an emulsifier and stabilizer to help mix oil and water components evenly throughout the medicine and prevent separation.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII 7G1J5DA97F
    White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.

18 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesAloe Vera Leaf Gel, Bees Wax White, BHT, Cetyl Alcohol, DMDM H, Glycerin, Glyceryl Stearate SE, Isopropyl Myristate, Mineral Oil, Nipagin, Nipasol, Polydimethylsiloxane (PDMS), Polysorbate 60, Polysorbate 20, Sesame Oil, Shea Butter, Sorbitan Tristearate, Water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 60 g 118.6 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
TerrasilMed ONC .5 g/100g 24909-0029-50 Aidance 50 g — — FDA listed —
terrasil Infection Protection Wound Care .5 g/100g 24909-0030-14 Aidance 14 g — — FDA listed —
terrasil Skin Repair .5 g/100g 24909-0032-14 Aidance 14 g — — FDA listed —
terrasil Scar Recovery .5 g/100g 24909-0043-28 Aidance 28 g — — FDA listed —
911 .5 g/100g 61328-0120-11 Skinfix, 50 g — — FDA listed —
ARC Skin Protectant .5 g/100gthis 69148-0001-02 Anjon 100 g — — FDA listed —
Healing Head to Toe .5 g/100g 69366-0508-29 The 141 g — — FDA listed —
Calm and Heal Melting Balm .5 g/100g 69366-0505-23 The 1 jar — — FDA listed —
Drs. pharmacy Scar Cream .5 g/100g 80489-0333-01 OL 1 tube — — FDA listed —
Advanced Bed Sore Wound Healing .5 g/100g 87512-0001-01 Yantai 15 g — — FDA listed —
Advanced Silicone Scar .5 g/100g 87512-0006-01 Yantai 20 g — — FDA listed —
Nasal Dryness Relief Gel .5 g/100g 10738-0051-10 Genuine 1 tube — — FDA listed —
Dermachange Scar .5 g/100g 83520-0297-00 Private 1 tube — — FDA listed —
Advanced Formula Scar Defense Cream .5 g/100g 87512-0002-01 Yantai 20 g — — FDA listed —
Teevodar .5 g/100g 69435-1301-01 PEER 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2014
On the market since
Aug 2014
📍
2026
Currently FDA-listed
12 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ALLANTOIN — the ingredient across all brands.

Top reported reactions

Nausea410
Vomiting289
Condition Aggravated238
Dyspnoea217
Abdominal Pain207
Somnolence196
Fatigue179

Age at onset

Adult14
Elderly52

Reporter sex

3,285 reports
Male · 46%
Female · 53%
Unknown · 0%

Serious outcomes

Hospitalization1,422
Death452
Life-threatening345
Disabling304
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 63 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69148-0001-00 118.6 g in 1 TUBE (69148-001-00) 2014-08-06 Discontinued by firm
69148-0001-01 60 g in 1 TUBE (69148-001-01) 2018-01-01 Active
69148-0001-02 You're viewing this 100 g in 1 TUBE (69148-001-02) 2024-04-22 Active

Pack size FAQ

What quantity is in NDC 69148-0001-02?
NDC 69148-0001-02 contains 100 g — 100 g in 1 tube.
What is the difference between NDC 69148-0001-02 and NDC 69148-0001-01?
Both are ARC Skin Protectant ALLANTOIN .5 g/100g Ointment — the drug itself is identical. NDC 69148-0001-02 is the 100 g package, while NDC 69148-0001-01 is the 60 g package.
What NDC number is used to bill for this package of ARC Skin Protectant ALLANTOIN .5 g/100g Ointment?
Bill NDC 69148-0001-02 — the 11-digit billing format is 69148000102. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 69148-001-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 69148-0001-02, written without dashes as 69148000102. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 69148-0001-02, the first segment (69148) is the labeler code FDA assigned to Anjon Biologics, Inc; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Anjon Biologics, Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 g (69148-0001-01), 118.6 g (69148-0001-00). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Anjon Biologics, Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 21 words ▾

Indication for use • ARC ® is a pre-radiation topical cream treatment for the protection against and management of Radiation Dermatitis.

⏱️ Dosage and Administration 72 words ▾

Directions • For topical use only. Apply ARC ® twice daily to all skin areas that will be exposed to radiation, or as directed by a health care professional. Can be applied 1-2 hours prior to treatment. Massage gently into the skin until absorbed. Continue use until treatment cycle is complete. Washing of the treated area will not reduce skin protection. ARC ® does not interfere with the effectiveness of radiation treatment.

⚠️ Warnings 20 words ▾

Warnings For external use only. Should you have an adverse reaction, consult your physician. Keep out of reach of children.

🧪 Active Ingredient 14 words ▾

Ingredients • Each gram contains 5 mg (0.5%) Allantoin in a cream base of

🧪 Inactive Ingredients 35 words ▾

Aloe Vera Leaf Gel, Bees Wax White, BHT, Cetyl Alcohol, DMDM H, Glycerin, Glyceryl Stearate SE, Isopropyl Myristate, Mineral Oil, Nipagin, Nipasol, Polydimethylsiloxane (PDMS), Polysorbate 60, Polysorbate 20, Sesame Oil, Shea Butter, Sorbitan Tristearate, Water

🎯 Purpose 4 words ▾

Protection Against Radiation Dermatitis

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69145-0924-04 · Desert 69155-0003-01 · Anhui →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.